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Anaplastic Large Cell Lymphoma, ALK-PositiveNCT03603847

Prospective Study of the Prognostic Value of New Markers in Adults With ALK-positive Large Anaplastic Lymphoma

An observational study of Anaplastic Large Cell Lymphoma, ALK-Positive, run by The Lymphoma Academic Research Organisation at 15 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study aims to evaluate the prognostic value on the complete metabolic response rate (MCR), the incidence of relapse / progression, the Progression Free Survival (PFS) and the Overall Survival (OS). at diagnosis after the first cycle of CHOEP (early evaluation) at the end of treatment Read more about this study

Who is it for?
Ages 18 years and older
How many people
41 participants
Where
15 sitesFrance
Study dates
2 Aug 2018to 16 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult Anaplastic large-cell lymphoma ALK+

Who may be able to join

  • Over 18 years old Diagnosed with Anaplastic large-cell lymphoma ALK+
  • Planned treatment : 6 cycles of CHOEP 21
  • Planned lumbar puncture at diagnosis or at the first cycle with intrathecal prophylaxis with methotrexate (15 mg) at the first cycle
  • Planned interim positron emission tomograph (PET)-scan after 3 cycles of treatment and at the end of treatment according to the center standard of care

Who cannot join

  • Involvement of the central nervous system
  • Intent of Autologous stem-cell transplant in first line

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

France15 sites

  • CHU Amiens - Hôpital Sud

    Amiens

  • CHU d'Estaing

    Clermont-Ferrand

  • APHP - Hopital Henri Mondor

    Créteil

  • CHU Grenoble

    Grenoble

  • CHRU de Lille - Hôpital Claude Huriez

    Lille

  • Institut Paoli Calmette

    Marseille

  • APHP - Hôpital Necker

    Paris

  • APHP - Hôpital Saint Louis

    Paris

  • CHU Bordeaux - Centre François Magendie

    Pessac

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • CHU de Rennes - Hôpital de Pontchaillou

    Rennes

  • Centre Henri Becquerel

    Rouen

  • CHRU de Strasbourg

    Strasbourg

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse

  • CHU Brabois

    Vandœuvre-lès-Nancy

Other trials in France

About this study

The study aims to evaluate the prognostic value on the complete metabolic response rate (MCR), the incidence of relapse / progression, the Progression Free Survival (PFS) and the Overall Survival (OS).

  • at diagnosis
  • after the first cycle of CHOEP (early evaluation)
  • at the end of treatment
Read the detailed description

ALK-positive anaplastic large cell (anaplastic large-cell lymphoma, ALCL) is a rare adult disease for which almost all published studies are retrospective. The overall survival (OS) at 5 years varies from 70 to 87%. A recent international pooled analysis showed that the International Prognostic Index (IPI) had good predictive value for the PFS and the OS.

In children, new prognostic factors have been identified: the titre of circulating anti-ALK antibodies (inverse correlation between the antibody titre and the prognosis), the detection of a NPM-ALK transcript in the blood at diagnosis (minimal disseminated disease, MDD); correlation between MDD positivity and pejorative prognosis) and its minimal residual disease (MRD), and the histological subtype (common versus small cells / lymphohistiocytic).

The predictive value of the oncogenic profile of ALK-positive ALCL and circulating tumor DNA will be studied in this study.

  • At diagnosis (before starting treatment):
  • Cycle 2 Day 1 (before starting cycle 2 treatment):
  • At the end of treatment evaluation: 40 patients treated with 6 cycles of CHOEP every 3 weeks and 1 lumbar puncture at diagnosis with intrathecal prophylaxis with methotrexate will be included prospectively.

During a 2-year period, relapses / progressions and patient deaths will be monitored for the calculation of the incidence of relapse / progression, progression free survival (PFS) and overall survival (OS).

Medical subject headings
Lymphoma, Large-Cell, Anaplastic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prognostic value of biological parameters on the complete metabolic response rate (MCR)

    Measured: Day 0

Secondary outcomes (11)

  1. Prognostic value of biological parameters on the complete metabolic response rate (MCR)

    Measured: 1 month

  2. Prognostic value of biological parameters on the complete metabolic response rate (MCR)

    Measured: 2 years

  3. Prognostic value of biological parameters on the incidence of relapse

    Measured: Day 0

  4. Prognostic value of biological parameters on the incidence of relapse

    Measured: 1 month

  5. Prognostic value of biological parameters on the incidence relapse

    Measured: 2 years

  6. Prognostic value of biological parameters on the Progression Free Survival (PFS)

    Measured: Day 0

  7. Prognostic value of biological parameters on the Progression Free Survival (PFS)

    Measured: 1 month

  8. Prognostic value of biological parameters on the Progression Free Survival (PFS)

    Measured: 2 years

  9. Prognostic value of biological parameters on the Overall Survival (OS)

    Measured: Day 0

  10. Prognostic value of biological parameters on the Overall Survival (OS)

    Measured: 1 month

  11. Prognostic value of biological parameters on the Overall Survival (OS)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2018
  2. Study start2 Aug 2018
  3. Primary completion16 Jun 2023
  4. Study completion16 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603847
Sponsor's protocol ID
ALK-OBS
Status last verified
Sep 2023
First submitted
18 Jul 2018
Last updated
26 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sibon D, Fournier M, Briere J, Lamant L, Haioun C, Coiffier B, Bologna S, Morel P, Gabarre J, Hermine O, Sonet A, Gisselbrecht C, Delsol G, Gaulard P, Tilly H. Long-term outcome of adults with systemic anaplastic large-cell lymphoma treated within the Groupe d'Etude des Lymphomes de l'Adulte trials. J Clin Oncol. 2012 Nov 10;30(32):3939-46. doi: 10.1200/JCO.2012.42.2345. Epub 2012 Oct 8.

    PubMed 23045585

  • Damm-Welk C, Mussolin L, Zimmermann M, Pillon M, Klapper W, Oschlies I, d'Amore ES, Reiter A, Woessmann W, Rosolen A. Early assessment of minimal residual disease identifies patients at very high relapse risk in NPM-ALK-positive anaplastic large-cell lymphoma. Blood. 2014 Jan 16;123(3):334-7. doi: 10.1182/blood-2013-09-526202. Epub 2013 Dec 2.

    PubMed 24297868

  • Damm-Welk C, Pillon M, Woessmann W, Mussolin L. Prognostic factors in paediatric anaplastic large cell lymphoma: role of ALK. Front Biosci (Schol Ed). 2015 Jun 1;7(2):205-16. doi: 10.2741/S434.

    PubMed 25961696

  • Lamant L, McCarthy K, d'Amore E, Klapper W, Nakagawa A, Fraga M, Maldyk J, Simonitsch-Klupp I, Oschlies I, Delsol G, Mauguen A, Brugieres L, Le Deley MC. Prognostic impact of morphologic and phenotypic features of childhood ALK-positive anaplastic large-cell lymphoma: results of the ALCL99 study. J Clin Oncol. 2011 Dec 10;29(35):4669-76. doi: 10.1200/JCO.2011.36.5411. Epub 2011 Nov 14.

    PubMed 22084369

Questions about this trial

What is this clinical trial studying?

An observational study of Anaplastic Large Cell Lymphoma, ALK-Positive, run by The Lymphoma Academic Research Organisation at 15 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prognostic value of biological parameters on the complete metabolic response rate (MCR) (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03603847, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.

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